The drug Alpha-1 Antitrypsin (AAT, Aralast NP), which is being tested in this clinical
trial, is an anti-inflammatory drug that affects the cells that are thought to be involved
in the development of type 1 diabetes. This trial, known as RETAIN, is a clinical trial is
a two-part trial investigating the effect of intravenous Alpha-1 Antitrypsin(AAT, Aralast
NP) on preserving beta cell function and to determine if AAT will help slow the progression
of type 1 diabetes.

Part I of this trial (NCT#) is an open-label, safety and dose level study consisting of two
groups. After Part I is completed, including a satisfactory safety review, enrollment in
Part II will begin. Part II is a two-arm, double-blind, placebo-controlled clinical trial,
and participants will be randomly assigned to either the treatment or placebo group.

Detailed description:
Type 1 diabetes mellitus is an autoimmune disease. This means that your immune system (the
part of your body that helps fight infections) mistakenly attacks the cells that produce
insulin (beta cells in the pancreas). As beta cells are destroyed by your immune cells,
your ability to produce insulin is decreased. Insulin helps keep blood glucose levels
normal.

People with type 1 diabetes who have the ability to produce some of their own insulin (even
though they still need to take insulin) may be able to achieve better glucose control than
people who produce no insulin at all. Better glucose control has been shown to reduce the
long-term complications of diabetes. Previous research has shown that giving medicines to
affect the immune system soon after type 1 diabetes is diagnosed may stop, delay or decrease
the destruction of beta cells, resulting in better glucose control.

In mouse models of disease, Alpha-1 Antitrypsin (AAT, Aralast NP) has been shown to reverse
new-onset diabetes and induce a state of self-tolerance. The RETAIN clinical trial is
investigating the effect of intravenous Alpha-1 antitrypsin(AAT, Aralast NP) on preserving
beta cell function and whether AAT will help slow the progression of type 1 diabetes.

Eligibility

Minimum age: 8 Years.
Maximum age: 35 Years.
Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with type 1 diabetes within the past 100 days

- Positive for at least one diabetes-related autoantibody (Anti-GAD; Anti-insulin, if

obtained within 10 days of the onset of insulin therapy; IA-2 antibody and/or ICA, or
ZnT8.)